The term is not anecdotal. While the organizations involved in medical research accuse Didier Raoult of having carried out a “wild” therapeutic trial at the IHU Méditerranée Infection”, the infectologist assured this Tuesday on BFMTV that “there has never been a therapeutic trial”, but “an observational study ” within the IHU of which he was director until September.
A therapeutic or clinical trial is a study of the efficacy and tolerance of a treatment “in a limited group of people before it is more widely available,” explains the National Agency for the Safety of Medicines and Health Products (ANSM), an establishment under the Ministry of Health, in its premises.
• What does the study say about the hydroxychloroquine in question?
In the case of the IHU Marseille case, the debate concerns the category of investigation that was carried out. From March 2, 2020 to December 31, 2021, the IHU adopted, as a reference treatment against Covid-19, a combination ofhydroxychloroquine (HCQ), used in particular against arthritis or lupus, and azithromycin (AZ), an antibiotic used in particular against bronchial infections.
Last April, A study has been previously published (meaning it has not been peer-reviewed or published in a scientific journal) to reveal the results of this treatment. The authors write there that hydroxychloroquine “prescribed early or late partly protects from covid-19-related deaths.”
• What are the different categories of searches?
In France, the Jardé law of March 5, 2012 defines three categories of research involving the human person. The first designates “research that involves an intervention on people that is not exempt from risk for them”, such as research on drugs, details the Ministry of Health on its site. Researchers must first obtain authorization from the ANSM and a Committee for the Protection of People (CPP), made up of members of the medical-scientific world and civil society.
The second category refers to “research with minimal risks and limitations.” The third is used for “observational” or “non-interventionist” research, which “does not involve any risk or restriction” and “in which all acts are carried out and the products are used in the usual way,” the ministry specifies. They only require the favorable opinion of a CPP, and not the authorization of the ANSM.
The ministry cites as an example the comparison of practices between two health centers or the observation of the tolerance of a drug after its commercialization.
• What is the status of the research at the IHU in Marseille?
The difference between these different categories is at the heart of the IHU Marseille affair. In a column published in The world This Sunday, 16 organizations involved in medical research believe that the Jardé law has been “widely and systematically flouted.”
They judge that the systematic prescription of hydroxychloroquine and azithromycin was carried out “outside any ethical or legal framework”, while the treatment was “indisputably shown to be ineffective, even risky” by several international studies.
The study claims 30,000 patients, the forum signatories say it is “probably” the “largest known ‘wild’ therapeutic trial to date.”
For Professor Raoult, his study falls more into the third category of research, it is an “observational study”: “We report all the patients and all the treatments they have had,” he said on BFMTV on Tuesday.
In this case, authorization from the ANSM would not have been required. The latter, however, indicated to the World that according to their “first analyses”, the study “should have benefited” from this authorization.
• What are the possible legal consequences?
The court will have to decide on this point. The senator from Paris, Bernard Jomier, announced on Twitter on Tuesday that he had contacted the Marseille prosecutor about the therapeutic protocol implemented at the IHU against Covid-19.
It should be noted that the Marseille public prosecutor’s office opened on July 4, 2022 a judicial investigation for interventionist investigation involving a human person not justified by his usual care without obtaining the opinion of the committee for the protection of people and the authorization of the ‘ ANSM – among others- after reports from the ANSM. This file refers to another investigation in addition to the one published in April.
The prosecutor’s office clarified this Tuesday to BFMTV that for the moment no one has been charged in this case. The Public Health Code provides for this type of infraction a sentence of one year in prison and a fine of 15,000 euros.
Source: BFM TV
